BR112013003683B1 - SAFETY NEEDLE DEVICE, PROTECTED NEEDLE ASSEMBLY, BLOOD COLLECTION ASSEMBLY AND METHOD FOR ACTIVATING A NEEDLE ASSEMBLY - Google Patents

Abstract

passively protected needle assembly with skin sensor. The present invention relates to a needle assembly that is provided with a connector that has a needle cannula that is provided with a connector that has a needle cannula with a puncture tip extending from its front end, and a protective member in telescopic association with the connector. a driving member activates the connector and the protection member apart for relative telescopic movement between a first position, in which the puncture tip extends from a forward end of the protection member, and the second position, in which the puncture tip puncture is encompassed within the protective member. a pivot lever holds the connector and shield member in the first position against activation of the drive member with the needle cannula exposed for use. the lever pivots during contact with the patient's skin surface, such as during venipuncture, thereby removing the connector and protective member from the first position and allowing the actuating member to activate the protective connector toward the second position .

Description

Field of Invention

[001] The present invention relates to blood collection sets for the safe and convenient handling of needles used in blood collection procedures. More particularly, the present invention relates to a blood collection set including a secure shield to protect users from a used needle tip.

Fundamentals of the Invention

[002] Disposable medical devices that have medical needles are used to administer medication or withdraw fluid from a patient's body. Such disposable medical devices typically include blood collection needles, fluid handling needles and sets thereof. Current medical practice requires that fluid containers and medical needles used in such devices be inexpensive and readily disposable. Existing blood collection devices often employ some form of reusable and durable container in which disposable, disconnectable medical needles and fluid collection tubes can be mounted. Such a blood collection device can be assembled before use and then discarded after use.

[003] A blood collection device or intravenous infusion (IV) device typically includes a needle cannula having a proximal end, a tipped distal end, and a lumen extending therebetween. The proximal end of the needle cannula is securely mounted in a plastic hub that defines a central passageway that communicates with the lumen extending through said needle cannula. A thin, flexible thermoplastic tube is connected to the hub and communicates with the lumen of the needle cannula. The end of the flexible plastic tubing remote from the needle cannula may include an attachment for connecting the needle cannula to a fluid collection tube holder or other receptacle. The specific construction of the fixture will depend on the characteristics of the receptacle to which the fixture will be connected.

[004] In order to reduce the risk of occurrence of an injury by accidental needle puncture, the protection of used needle cannulas becomes important. Considering infection and disease transmission, methods and devices to wrap and cover the used needle cannula have become very important and in great demand in the medical field. For example, needle sets often employ a safety shield that can be moved into secure engagement with a used needle cannula to minimize the risk of accidental needle piercing.

Prior art devices in this area often include flexible fins that are used as devices to secure sets of needles to a patient's body during a medical procedure. Assemblies of finned needles typically include a barrel or body part, a fin part mounted to the body part, and a needle cannula. The fin portion can be used to manipulate the assembly during insertion and withdrawal of the patient's needle cannula. The fin portion is also used to stabilize the assembly against the patient's skin, providing a surface area for bandaging, coupling, etc. to the patient to prevent the movement of the set.

[006] The US Patent. No. 7,294,118 of Saulenas et al. describes a retractable push-button needle assembly in which a needle is attached to a cube and extends through a barrel. A push-button actuator extends from the hub and is in interference engagement with the drum. Activation is performed with a user actively pressing the pressure button for the drum, thus causing the needle to retract inside said drum through the pressure of a spring disposed between the hub and the drum.

[007] Needle sets may also incorporate passively activated safety features. In such devices, the needle guard feature is passively activated through normal use of the device. For example, activation of the safety feature can occur automatically, such as upon removal of an outer safety packaging cap and after the user releases the device after insertion of the needle into the patient's injection site. The safety feature can be a safety shield that is pushed towards the tip of the needle, or a force that is exerted on the needle to retract the needle into the body of the device. US Patent. No. 6,682,510 by Niermann describes a passive safe blood collection set that includes a tip guard slidably moved along a needle cannula. The tip guard is mounted to a needle hub through a pair of shrunk sheets, which are shrunk back on themselves and held in place by a packaging lid. In use, the practitioner holds the leaves in a contracted or folded state to remove the cap, then releases them allowing them to unfold to propel the tip guard distally.

[008] Such passively actuated devices typically involve a relative axial force between the needle and the shield to activate the safety feature. If this relative axial force is greater than the drag force provided by the friction between the needle and the patient's tissue, said needle may be self-ejected from the patient during activation of the safety feature.

Invention Summary

[009] There is a need for a blood collection set including a shielded needle set that achieves effective and safe protection of a used needle cannula. There is an additional need for a blood collection set with a shielded needle set that is passively operated, and such that activation of the safety feature does not cause the needle cannula to self-eject from the patient. There is an additional need for a passively operated shielded needle assembly that provides a guide to help locate an ideal puncture site.

[010] A safety needle device is provided including a hub having a needle cannula with a puncture tip extending from its forward end, and a protective element in telescopic association with the hub. The hub and guard element are adapted for telescopic movement relative to each other between a first position in which the puncture tip of the needle cannula is exposed from a forward end of the guard element, and a second position in the which the puncture tip of the needle cannula is enclosed within the protective element. A drive element is arranged between the hub and the protection element and is capable of activating said hub and the protection element telescopically away from each other, that is, towards the second position. A contact element holds the hub and guard element in first position against activation of the drive element with the needle cannula exposed from a front end of the guard element. The contact element comprises a lever in pivotal engagement with the guard element including a front portion adjacent to the puncture tip of the needle cannula and a rear portion including frame for releasably holding the hub and shield in the first position. The contact element is moved during contact with the patient's skin surface, thus allowing the release of the hub and protective element from the first position and allowing the actuating element to activate the hub and protective element towards the second position.

[011] In one embodiment, releasing the contact element from the patient's skin surface allows the drive element to telescopically activate the hub and protection element away from each other to the second position with the puncture tip of the needle cannula enclosed within the protective element.

[012] The rear portion of the contact element lever may include a first engagement portion to engage with the hub and hold the hub and shield in first position, with the first engagement portion being releasable from engagement with the hub upon movement pivoting of the lever during contact with the patient's skin surface. The rear portion of the lever may further include a second engagement portion for engaging the hub upon pivotal movement of the lever during contact with the patient's skin surface to prevent the hub from being fully activated to the second position when the first member engages. hitch is released from hitch with hub. The second engagement portion is releasable from engagement with the hub by pivoting movement of the lever in a reverse direction during release of contact with the patient's skin surface.

[013] A further embodiment of the invention is directed to a protective needle assembly comprising a needle cannula with a puncture tip at a distal end thereof and with a needle hub supporting said needle cannula. The needle hub is disposed within the passage of a barrel that extends between a proximal end and a distal end. A drive element, such as a spiral spring, is further disposed between the barrel and the needle hub to drive said needle hub from a first position, in which the puncture tip of the needle cannula is exposed from there. from the distal end of the barrel, to a second position, where said puncture tip of the needle cannula is disposed entirely within the barrel. A lever is pivotally connected to the barrel and includes a front portion adapted to contact the patient's skin surface and a rear portion including releasable engagement with the needle hub to hold said needle hub in first position. Contacting the front of the lever with the patient's skin surface rotates the lever and releases initial engagement with the needle hub at the rear of the lever.

[014] The rear portion of the lever may include a first engagement portion that engages a needle hub portion to hold said needle hub in the first position. In this way, contacting the front part of the lever with the patient's skin and/or inserting the needle cannula through the patient's skin causes the lever to rotate with respect to the drum, such that the first engaging part of the needle hub disengagement lever. Furthermore, the rear portion of the lever may further include a second engagement portion for engaging the needle hub. In this way, contacting the front part of the lever with the patient's skin and/or inserting the needle cannula through the patient's skin causes the lever to articulate with respect to the drum, such that the first engaging part of the The needle hub disengagement lever and the second lever engagement portion hold the needle hub in a position with the punch tip extending from the front end of the barrel. Furthermore, the second engagement portion of the lever disengages from the needle hub upon pivotal movement of the lever with respect to the barrel in a reverse direction during removal of the front portion of said lever from the patient's skin surface, such as during removal of the needle cannula of the patient's skin. In this way, the drive element drives the needle hub to a position where the puncture tip of the needle cannula is disposed entirely within the barrel.

[015] The lever can be molded integrally with the drum, or it can be a separate element that is pivotally connected to the drum, such as through a pivot pin. Desirably, the front portion of the pivot lever can be configured to interface with a patient injection point through the puncture tip of the needle cannula, and can include a hollow pad.

[016] In a further embodiment of the invention, a blood collection set includes such a shielded needle set, with a flexible tube extending from the needle hub, and with an opposite end of said flexible tube adapted to fit. connect to a receptacle to accommodate a blood collection tube. For example, the opposite end of the flexible tubing may include a needle cannula opposite the patient, or it may include a hub including a female luer hub that is adapted to fit a separate element including a needle cannula opposite the patient. of the patient.

[017] An additional modality involves a method to activate a needle set. A needle assembly is provided comprising a hub including a needle cannula with a puncture tip extending from a forward end thereof, with the hub at least partially disposed within a protective element and activated towards a position. in which the puncture tip of the needle cannula is enclosed within the protective element. The needle assembly further comprises a pivoting lever connected to the barrel and including a first engagement with the hub to hold said hub activated against the exposed punch tip from a forward end of the shield. The method involves inserting the puncture tip of the needle cannula through a patient's skin such that the pivot lever contacts the patient's skin surface and causes the lever to articulate with respect to the protection, thus removing the first engagement between the lever and the hub.

[018] The insertion step can also provide the engagement of a second engagement between the lever and the hub by releasing the first engagement. In addition, the method may further comprise a step of removing the puncture tip of the needle cannula from the patient's skin so that the pivot lever releases from contact with the patient's skin surface and articulates with respect to the protective element at an opposite direction. In this way, the second engagement between the lever and the hub is released, allowing the hub to be activated towards a position in which the puncture tip of the needle cannula is enclosed within the protective element.

[019] Additional details and advantages of the invention will become apparent upon reading the following detailed description in conjunction with the accompanying drawings, where like reference numbers identify like parts.

Brief Description of Drawings

[020] FIG. 1 is an exploded perspective view of a blood collection set including a shielded needle set, in accordance with an embodiment of the present invention.

[021] FIG. 2 is a perspective view of the assembly of FIG. 1 in a mounted condition.

[022] FIG. 3 is a perspective view of the skin sensor of the assembly of FIG. 1.

[023] FIG. 4 is a side plan view of the skin sensor of FIG. 3.

[024] FIG. 5 is an exploded perspective view of parts of the needle assembly shown in conjunction with the embodiment of FIG. 1.

[025] FIG. 6 is a perspective view of the needle assembly of FIG. 5 in a mounted condition.

[026] FIG. 7 is a side view of the needle assembly of FIG. 5 without a needle guard over the needle cannula.

[027] FIG. 8 is a longitudinal cross-sectional view of a housing of the needle assembly of FIG. 1.

[028] FIG. 9 is a perspective view of the needle assembly of FIG. 1 in an initial state showing a needle cannula protruding from the housing.

[029] FIG. 10 is a side view of the needle assembly of FIG. 9.

[030] FIG. 11 is a top cross-sectional view taken along line 11-11 in FIG. 10.

[031] FIG. 12 is a side cross-sectional view taken along line 12-12 in FIG. 11.

[032] FIG. 13 is a side cross-sectional view of the needle assembly of FIG. 1 shown in use with a needle cannula piercing the patient's skin.

[033] FIG. 14 is a perspective view of the needle assembly shown in FIG. 1 with the needle cannula in a retracted position.

[034] FIG. 15 is a side cross-sectional view of the needle assembly of FIG. 14.

[035] FIG. 16 is a perspective view of the needle assembly in accordance with an alternative embodiment of the present invention.

[036] FIG. 17 is a side cross-sectional view in accordance with a further embodiment of the invention.

[037] FIG. 18 is a side cross-sectional view of the needle assembly of FIG. 17 shown in use with a needle cannula piercing the patient's skin.

[038] FIG. 19 is a side cross-sectional view of the needle assembly of FIG. 17 shown in a protected position.

Detailed Description of the Invention

[039] For purposes of the following description, the words "top", "bottom", "right", "left", "vertical", "horizontal", "top", "base", "lateral", "longitudinal" and similar spatial terms, if used, refer to the modalities depicted as oriented in the figures. However, it is understood that many variations and alternative modalities may be assumed, except where otherwise expressly specified. It is also understood that the specific devices and embodiments illustrated in the accompanying drawings and described herein are simply exemplified embodiments of the invention.

[040] Generally, an embodiment of the invention relates to a passive retraction needle assembly with a pivoting lever with skin sensor. The skin sensor lever is designed to capture the action of needle insertion and removal by a healthcare professional and passively activate the safety device after these two occurrences are completed, without the need for any other concise action by the healthcare professional. Activation of the safety device does not create a relative axial force that is large enough to cause the needle cannula to self-eject from the patient. In addition, the skin sensor lever can provide a guide to help locate a puncture site, and can distract needle phobic patients from the negative visual impact of an exposed needle. The invention is generally described in terms of a shielded needle set for use in a blood collection or infusion set, and encompasses the needle set as well as an infusion or collection set.

[041] As shown generally in FIGs. 1 and 2, a fluid collection/infusion set is shown as a blood collection set 1 including a safety guard device or needle set 2, flexible tubing 3 extending from the device or needle set 2 , and a protective cap or shield such as needle shield 29 which forms a packaging cap detachably mounted to needle assembly 2 opposite flexible tube 3, such as by frictional engagement thereto. A first end or proximal end 17 of flexible tube 3 is adapted to connect with a receptacle for blood collection, while needle assembly 2 extends from a second end or distal end 19 of flexible tube 3.

[042] Tube 3 includes the proximal end 17, the distal end 19 and a passageway extending between the ends. Tube 3 can be a conventional IV tube used in conventional blood collection sets. The proximal hub 5 is unitarily molded from a plastics material and includes a proximal end 21, a distal end 23 and a passageway extending between the ends. Portions of the distal end adjacent to passage 23 are configured to be telescopically clamped over proximal end 17 of tube 3 such that passage through tube 3 communicates with passage through proximal hub 5. Proximal end 21 of hub 5 can define, for example, a female luer cube that can be fitted to a male luer cube suitable for infusing a medication into a patient. For example, a male luer hub at the distal end of a conventional syringe can be directly connected to the proximal hub 5 to infuse a patient with medication. In this case, a separate male luer cap can be provided to close the proximal hub 5. Alternatively, the hub 5 can be adapted to accommodate a needle assembly opposite the patient including an elastomeric sheath, such as an engaged male luer hub. to cube 5, as known in the art. In such an embodiment, a conventional needle holder can be fitted with the needle opposite the patient so that it is placed in communication with an evacuated blood collection tube, thus providing a blood collection set in known manner. Other hubs may be engaged with the proximal hub 5, in accordance with the specific intended use of the collection/infusion set 1. Additionally, hubs of other configurations may be employed to achieve a particular purpose.

[043] As noted, blood collection set 1 includes a device or needle set 2 extending from flexible tube 3. Referring to FIGs. 1 and 2, an embodiment of the invention defines the shielded needle assembly 2 as generally including a needle portion 7 which includes a needle cannula 25 together with a needle hub 27, a safety shielding element 8 including an assembly barrel comprising a front drum 11, a rear drum 13 and a finned structure 15, a drive element such as spring 9 for moving the needle portion and the protective element together, and a contact element such as a lever with skin sensor 16.

[044] With respect to FIGs. 2-7, a needle portion 7 includes a needle cannula 25, a needle hub 27, and optionally, a needle guard 29. The needle guard 29 may be formed to interfere with the pivotal movement of the sensor pivot lever. skin 16 allowing lever 16 to be retracted in a downward position during transit and storage. The needle cannula 25 has a proximal end 31, a distal end 33 and a lumen extending between the ends. The distal end 33 of the needle cannula 25 is bevelled to a sharp puncture tip 35, such as an intravenous puncture tip. The puncture tip 35 is provided for insertion into a patient's blood vessel, such as a vein, and is then designed to provide easy insertion and minimal discomfort during venipuncture.

[045] The needle hub 27 can be unitarily molded from a plastic material such as polycarbonate, polypropylene, polyethylene, acrylic, polystyrene and ABS. Needle hub 27 may be molded from a transparent or translucent material to enable observation of blood or other fluid flowing through needle hub 27. Needle hub 27 includes a rear or proximal end 59, a forward end or distal 61, and a passage extending between the ends. Portions of the proximal end adjacent passage 59 are sized to receive distal end 19 of tube 3. More particularly, distal end 19 of tube 3 may be shortened in passage of needle hub 27 and glued to the proximal end adjacent passage 59 of needle hub 27. Portions of the distal end adjacent passage 61 of needle hub 27 may be sized to slidingly receive proximal end 31 of needle cannula 25.

[046] With respect to FIG. 8, and with reference to FIGs. 2 to 7, the protective element 8 is in telescopic association with the needle part 7, and in particular with the needle hub 27, with at least one of the needle hub 27 and/or the protective element 8 adapted to telescopic movement relative to each other. In particular, the needle hub 27 and the shielding element 8 are moved axially with respect to each other between a first position, in which the punch tip 35 of the needle cannula 25 is exposed from the front end of the shielding element. 8 as shown in FIG. 9, and a second position, in which the puncture tip 35 of the needle cannula 25 is enclosed within the protective element 8 as shown in FIG. 14. This can be achieved by providing the needle hub 27 in a sliding engagement within the protective element 8.

[047] The protective element 8 is generally tubular or cylindrical in shape, and may be a unitary structure, desirably molded from a thermoplastic material. In one embodiment, the protective element 8 comprises a drum assembly including a front drum 11, a rear drum 13 and a finned structure 15. The front drum 11 may be a substantially tubular unitarily molded plastic structure with proximal and distal ends. opposites 73 and 75, and a passage 77 extending between the ends. The rear drum 13 may also be a substantially tubular structure with a proximal end 93, a distal end 95 and a passage 97 extending between the ends. The passage 77 of the front barrel 11 is further defined by an annular locking rib 83 near the proximal end 73, while the outer portions of the rear drum 13 adjacent the distal end 95 define an annular locking ring 94. The locking rib 83 and the locking ring 94 allow locked engagement of the front and rear drums 11 and 13. In particular, the locking ring 94 is configured for lockingly engagement with the annular locking rib 83 in the passage 77 of the front drum 11 to engage the front and rear drums 11 and 13 with each other. The engagement of the front and rear drums 11 and 13 can be made more permanently by adhesive gluing, welding, or by increasing the interference between the annular locking rib 83 and the locking ring 94. Alternatively, the front drum 11 and the rear drum 13 can be connected by threaded engagement, where one of the front and rear drums 11 and 13 has external threads and the other has internal threads.

[048] The front barrel 11 includes an annular step 81 within the passage 77. The annular step 81 defines an inner diameter smaller than the outer diameter of the flange 67 on the needle hub 27. Thus, the annular step 81 defines a fixed boundary for distal movement of the needle hub 27 on the front barrel 11. Likewise, the proximal portions of the passage 97 through the rear barrel 13 are characterized by an internally extending proximal flange 101. The proximal flange 101 has a smaller internal diameter than the outer diameter of the flange 67 of the needle hub 27. Thus, the proximal flange 101 limits the proximal movement of the needle hub 27 in the rear drum 13.

[049] As noted, the needle hub 27 and the protective element 8 are moved axially to each other. Needle assembly 2 further includes a drive element such as a spring 9 which extends between needle hub 27 and shielding element 8, providing an activating force to activate needle hub 27 and shielding element 8 axially or longitudinally away from each other. The actuating element or spring 9 is generally positioned coaxially with the protective element 8 and/or the needle hub 27, with the needle assembly 2 in the first position. The actuating element may be in the form of a spiral compression spring or similar activating element and is generally adapted to move the protective element 8 and/or the needle hub 27 with each other between the first position and the second position of the needle assembly 2. The activating force of the actuating element is described here in terms of activating the needle hub 27 and the protective element 8 with each other, such as an activating force which activates the needle hub 27 and the element. protection 8 axially away from each other. It is noted that the activation of the needle assembly 2 is based on that activation force of the drive element inducing movement of either the needle hub 27 and the guard element 8, or the movement of both relative to each other. For example, if the user is holding the needle hub 27 during activation, the activating element will cause the shielding element 8 to extend or move distally with respect to the needle hub 27 to the second shielding position. of needle assembly 2. On the other hand, if the user is holding the shielding element 8 during activation, the activating element will induce the needle hub 27 to retract or move proximally with respect to the shielding element 8 to the second shield position of needle set 2.

[050] As described in the figures and with respect to FIGs. 1 and 11, the spring-shaped actuating element 9 has a first end which is generally arranged around the needle hub 27, and a second end which is generally in contact with a part of the protective element 8. Eng For example, the outer portions of the adjacent distal end 61 of the needle hub 27 may define a small diameter cylindrical tip 63 with an intermediate diameter cylindrical spring mounting section 65 extending proximally from said cylindrical tip of small diameter 63, and a larger diameter cylindrical flange 67 extending outwardly at the proximal end of the spring mounting section 65. The flange 67 defines a limit for the proximal movement of the spring 9 in the needle hub 27 and a limit for distal movement of needle hub 27 relative to front barrel 11. In addition, portions of passage 77 near distal end 75 of front barrel 11 may define an annular distal flange extending inward. spring 79 with an inner diameter smaller than the outer diameter of spring 9. Thus, distal flange 79 defines a distal stop for spring 9 and causes spring 9 to be compressed into front barrel 11. annular step 81 is spaced from distal flange 79 by a distance substantially equal to the compressed length of spring 9. Thus, the section of passage 77 between distal flange 79 and annular step 81 effectively defines a spring housing.

[051] In a general sense, the needle hub 27 and the protective element 8 are restricted from movement with respect to each other against the activating force of the spring 9 to keep the needle assembly 2 in the first position with the tip of punch 35 extending from the front end of the guard through the distal end 75 of the front barrel 11. The needle hub 27 and guard member 8 can be held in this way by a releasable catch adapted to hold the needle hub 27 and the protective element 8 in position with respect to each other against the actuating force of the spring 9. For example, the needle hub 27 and the protective element 8 may include an inter-engaging structure that provides an engagement between the hub of needle 27 and shielding element 8 to prevent spring 9 from activating needle hub 27 and shielding element 8 away from each other in a longitudinal direction, such as through the pivoting lever with skin sensor 16.

[052] With respect to FIGs. 3 and 4, and continuing with FIGS. 1 and 2, the skin sensor pivot lever 16 includes a front part 49 and a rear portion 51. The skin sensor pivot lever 16 is coupled to the front drum 11 forming a pivot shaft 53 substantially perpendicular to an axis of the front barrel 11, the needle hub 27 and the needle cannula 25. The pivot shaft 53 is generally located adjacent the upper surface of the front barrel 11. The front portion 49 of the lever 16 may be adapted in such a way as to interface with the patient's injection point by aligning the needle cannula 25. The front 49 of the skin sensor pivot lever 16 may further include a hollow pad. The hollow cushion offers more surface area and patient comfort. Desirably, the skin sensor pivot lever 16 pivots about the pivot axis 53 such that the front part 49 moves in an upward and downward fashion, with the upward direction being away from the patient's injection point and the downward direction being in the direction of the gate. The rear portion 51 also moves in an upward and downward fashion, opposite the front portion 49 by virtue of the location of the pivot shaft 53.

[053] The rear portion 51 of the lever 16 interfaces with the needle hub 27 to hold the needle hub 27 against activation of the spring 9. In particular, the needle hub 27 is configured to include a first recess 69 and a second recess 71 as shown in FIGs. 5 to 7. The first recess 69 and the second recess 71 are designed to interact with the first engaging element 55 and the second engaging element 57 of the skin sensor pivot lever 16, respectively, so as to maintain the hub of needle 27 in a forward position against the force of spring 9, as will be discussed in more detail here.

[054] The front barrel 11 further includes an opening 91 which extends through the top wall surface thereof and communicates with the passage 77. The opening 91 is sized and configured to receive the rear 51 of the lever pivoting with skin sensor 16 allowing the first engagement element 55 and the second engagement element 57 to interact with the first recess 69 and the second recess 71, respectively, of the needle hub 27.

[055] In one embodiment, the pivot shaft 53 may be formed through a lever bar arrangement, where the skin sensor pivoting lever 16 is connected to the front drum 11 through a pin and hole arrangement. For example, pin 52 may be formed integrally with the underside of lever 16, as shown in FIGs. 3 and 4. Pin 52 may be positioned at any location along lever 16, and is desirably positioned between first engaging element 55 and second engaging element 57. Pin 52 is desirably cylindrical in cross-section. In order to form a pivot shaft 53 between lever 16 and front drum 11 and to provide a mechanism for coupling said lever thereto, front drum 11 is further provided with a structure forming a corresponding guide surface to accommodate pin 52 pivotally through opening 91. For example, parts of the wall forming front drum 11 can be cut away on opposite sides thereof in such a way as to accommodate pin 52 in said front drum 11. As shown in FIGs. 1, 2 and 9, such cut-out parts of the wall of the front drum 11 can be profiled so as to form guide surfaces 50a and 50b on opposite sides thereof. Guide surfaces 50a and 50b act as a resting surface for pin 52 of lever 16, thus providing a mechanism for engaging and retaining lever 16 to front drum 11, through a fit thereto, and provide a hinge-type engagement for rotate around pivot axis 53.

[056] In an alternative embodiment, it is further noted that the front drum 11 may be formed with a front support and a back support spaced apart, and each including a surface profile to accommodate the outer surface of the pin 52. spacing the front and rear bearings forms a guide surface therebetween to accommodate an outer surface of the pin 52 in a hinge-like pivotal fashion. The front and rear supports may be formed integrally within the inner surface of the front drum 11, and may individually represent a continuous structure extending through opening 91. Alternatively, each of the front and rear supports may be partial support structures that extend from opposite sides of the inner surface of front drum 11 to opposite sides of opening 91, thus providing a guide surface to accommodate an outer surface of pin 52.

[057] Alternatively, the skin sensor pivot lever 16 can be molded integrally directly to a part of the front drum 11. For example, one or more thin flexible elements can be provided to create a live hinge that is integrated with the front drum 11.

[058] The outer circumferential surface of the front drum 11 may be defined by an annular finned mounting bottom layer 85 near the distal end 75. The annular bottom layer 85 is provided with detents 87 to position the finned structure 15 in an orientation rotational fixed to the front drum 11. The finned structure 15 is typically molded unitarily from an elastic material, such as polyolefin, polyvinyl chloride, or other such elastomeric polymers. The finned structure 15 includes flexible side panels 37 and 39 and a tubular support 41. The tubular support 41 includes an internal passage 43 that is sized for comfortable engagement over the front drum 11. The panels 37 and 39 are molded with a surface of top that is relatively soft. Meanwhile, the top surface of the panel 37 includes a pair of arcuate projections 45 on remote portions of the tubular support 41. The top surface of the panel 39 includes a pair of arcuate recesses 47 which are sized, arranged and configured to receive the projections 45 on panel 37, when panels 37 and 39 are folded such that the top surfaces thereof are in face-to-face engagement with each other. The interengagement of projections 45 with recesses 47 ensures that folded panels 37 and 39 function as a handle without sliding between them. The base surfaces of panels 37 and 39 may be provided with a plurality of tactile reliefs (not shown). The tactile embossing makes it easy to grip the bent panels 37 and 39 between the user's thumb and index finger. The color of finned structure 15 may designate the gauge of needle cannula 25. Alternative embodiments, where finned structure 15 has only one side panel 37 or 39, are noted to provide an alternative means of manipulating the needle assembly by user.

[059] The lower annular layer 85 of the front drum 11 may further have a damping agent injection port 89 for injecting a damping agent into passage 77. The damping agent injection port 89 may then be covered by the finned structure 15.

[060] The rear drum 13 may further include resiliently flexible locking fingers 103 that are proximally and internally cantilevered from opposite locations on the rear drum 13. Each locking finger 103 includes a proximal end 105 that is spaced apart from the proximal flange 101 by a distance equal to or slightly greater than the axial thickness of the flange 67 on the needle hub 27. Therefore, the flange 67 can be captured between the distal surface of the stop flange 101 and the locking fingers 103. The proximal ends 105 of the locking fingers 103 are spaced apart by a distance less than the diameter of flange 67 on needle hub 27.

[061] With respect to FIG. 9, and with further reference to FIGs. 1 to 8, the fluid collection/infusion assembly 1 is assembled by first constructing the needle part 7. The needle part 7 is constructed by fitting the proximal end 31 of the needle cannula 25 into the hub passage. of needle 27. The needle cannula 25 may be secured in that position by an adhesive, such as an ultraviolet ray or heat cured epoxy adhesive. The needle cannula 25 is oriented such that the puncture tip 35 at the distal end of the needle cannula 25 and the finned structure 15 are symmetrical about a common plane. Distal end 19 of tube 3 is then secured to proximal end 59 of needle hub 27. Tube 3 can be secured in that position by solvent gluing, adhesive gluing or by soldering.

[062] The assembly continues by shortening the spring 9 over the spring mounting section 65 of the needle hub 27. The needle portion 7 and spring 9 are then aligned and shortened in a distal direction to the front barrel 11, thereby compressing the spring 9. The rear portion 51 of the skin sensor pivot lever 16 is then positioned in the opening 91 of the front drum 11, allowing the first engaging element 55 and the second engaging element 57 to interact with the front recess 69 and the Rear recess 71, respectively, of the needle hub 27. The interaction between the engagement members 55 and 57 and the recesses 69 and 71 holds the needle hub 27 in a forward position against the force of the compressed spring 9. Skin sensing pivot lever 16 is positioned to form a pivot shaft 53 which is perpendicular to front barrel 11, needle hub 27 and needle cannula 25. Pivot shaft 53 may be created by a pin and bore arrangement or , alternatively, the pivoting lever with sensor of skin 16 can be molded integrally with front drum 11 to form something like a hinge.

[063] The finned structure 15 is then mounted over the distal end 75 of the front drum 11. The inner passage 43 of the tubular support of the finned structure 15 is aligned with detents 87 in the front drum 11. Thus, an adjustment is achieved. The tubular support 41 of finned structure 15 with annular bottom layer 85 and detents 87 is suitable for housing finned structure 15 on front drum 11 and to prevent rotation. In this assembled condition, panels 37 and 39 of finned structure 15 define a plane extending substantially normal to the plane of symmetry defined by punch tip 35 at distal end 33 of needle cannula 25 and skin sensor pivot lever 16 .

[064] The assembly still continues by threading the distal end 19 of tube 3 through the rear drum 13. Sufficient distal movement of the rear drum 13 along the tube 3 enables locked engagement of the distal end 95 of the rear drum 13 within the end proximal 73 of the front barrel 11. The proximal hub 5 can then be attached to the proximal end 17 of the tube 3.

[065] When viscous damping agent is used, the passage 77 of the front barrel 11, the spring mounting section 65 of the needle hub 27 and the distal surface of the flange 67 on the needle hub 27 define a chamber that restricts the location preferred buffering agent. An injection port 89 located within the side wall of the front drum 11 is used to dispense the viscous dampening agent into the chamber. The dampening agent can be injected through a dosing cannula that has a distal end to fit within the injection port 89. It is also noted that the damping agent can be applied to the passage 77, the spring 9 and the hub of needle 27, or any of the three components before assembly to produce a speed of change on retraction.

[066] The viscous damping agent can be a silicone that works to slow the needle hub 27 relative to the front drum 11 and the rear drum 11. The viscous damping agent creates a resistance to stop the retraction of the needle hub 27 and the needle cannula 25. An example of a buffering agent is a thixotropic gel, similar to the gel used as a separating gel in blood collection tubes. A thixotropic gel used as a damping agent provides unique properties with respect to spring 9. In particular, the thixotropic gel exhibits the ability to temporarily and elastically bond adjacent coils of spring 9 together. Initiating retraction releases the stored energy of spring 9 and allows it to expand. The thixotropic gel creates similar strength to silicone and therefore slows down the 27 hub and 25 needle cannula. However, unlike conventional silicone, the temporary bond between the two adjacent spirals achieved by the thixotropic gel provides a slower initial acceleration . The slower initial acceleration results in a significant reduction of splash during retraction of the 25-needle cannula. The use of thixotropic gel as described above as a cushioning agent does not limit the present invention to the use of other possible cushioning agents.

[067] The injection port 89 can be positioned in the lower annular layer 85 and can be sealed by locating a structure with fins 15 and covering the injection port 89, thus restricting the damping agent to that spring part 9 close to the injection port 89. Alternatively, it is understood that the damping agent may be located on sliding engagement surfaces between the needle hub 27 and the front and rear drums 11 and 13. This would produce a viscous shear boundary layer which would also can change the speed and acceleration of retraction of the needle hub 27.

[068] With respect to FIGs. 10 to 14, and with further reference to FIG. 9, the fluid collection/infusion assembly 1 is used by the folded panels 37 and 39 of the finned structure 15 towards each other and in face-to-face engagement, such that the projections 45 on the upper surface of the panel 37 are received in recesses 47 in the upper surface of panel 39 to prevent displacement of said panels 37 and 39. The tactile embossments (not shown) in the base surfaces of panels 37 and 39 can then be held securely in face-to-face engagement between a thumb. and the index finger. Needle guard 29 is then separated from needle hub 27 to expose needle cannula 25. In that condition, the plane defined by adjacent surfaces of panels 37 and 39 of frame 15 will be in the plane of symmetry of puncture tip 35 of the cannula. of needle 25.

[069] Furthermore, the front part 49 of the skin sensor pivot lever 16 is in a downward position that is lower than the needle cannula 25. The skin sensor pivot lever 16 is activated in that position by engaging the first engaging element 55 with front recess 69. The healthcare professional then orients the puncture tip 35 of the needle cannula 25 into a desired location on the patient and employs the proximal hub 5 on the proximal end 17 of the tube 3 for connection to a container. evacuated or a source of fluid that will be infused into the patient. The hollow arrangement on the front 49 of the skin sensor pivot lever 16 exposes the needle cannula 25, not hiding it or the injection site. Furthermore, this hollow arrangement also acts as a guide to help locate the ideal puncture site.

[070] As the needle cannula 25 is inserted into the patient, the skin sensor pivot lever 16 rotates, thus the front part 49 of the lever 16 is forced to move upwards to at least the level of the cannula of needle 25, which, in turn, moves the first engagement member 55 to an upward position based on the location of the pivot shaft 53. engaging element 55 disengaging from front recess 69, thereby releasing interference engagement between needle hub 27 and lever 16. This release of interference engagement allows the spring to exert an activating force between mating surfaces of the needle hub 27 and of the front barrel 11, allowing the needle assembly 2 to be driven or actuated towards a second position with the puncture tip 35 of the needle cannula 25 enclosed within the front barrel 11 and rear barrel assembly 13. For example, spring 9 exerts a force between needle hub 27 and front barrel 11 so that they are moved axially and/or telescopically with each other. The activation force exerted between the needle hub 27 and the front barrel 11 may be less than the friction force between the needle cannula and the patient's skin at the venipuncture point, thus preventing the needle cannula from retracting from the the patient's skin. Alternatively, the existence of a secondary interference engagement between the pivot lever 16 and the needle hub 27 is observed, after the initial rotation of the pivot lever upon contact with the patient's skin and/or during venipuncture.

[071] For example, such secondary engagement may be provided through interference engagement of the second engagement member 57 on the rear 51 of the pivot lever 16 with the rear recess 71 of the needle hub 27 as shown in FIG. 13. The second engagement member 57 of pivot lever 16 may be engaged with rear recess 71 of needle hub 27 prior to initial or upward pivotal movement of pivot lever 16 about pivot shaft 53 during contact and insertion or , more desirably, engages rear recess 71 during such initial or upward pivotal movement. In this way, the needle hub 27 is allowed to slide at least a minimum distance back based on the force exerted by the spring 9 until it is stopped by the engagement of the second engagement member 57 with the rear recess 71, as shown in FIG. 13. Skin Sensor Pivot Lever 16 remains in this configuration during injection or infusion.

[072] Upon completion of the medical procedure, the healthcare professional removes the 25 needle cannula from the patient. Removal of the needle cannula 25 causes the front part 49 of the skin sensor pivot lever 16 to move downwardly from its original position, causing the skin sensor pivot lever 16 to rotate about the pivot axis 53 in the opposite or reverse direction. This causes the second engaging element 57 to move up and out of the rear recess 71, while the first engaging element 55 is simultaneously moved downwards to a position that does not engage the front recess 69. Therefore, it is permissible that the spring 9 expands and urges the needle part 7 proximally. The proximal movement of the needle portion 7 ends when the flange 67 abuts the proximal flange 101 of the rear barrel 13. In this position, the entire needle cannula 25 is securely disposed within the front and/or rear barrels 11 and 13 , as shown in FIG. 15.

[073] As the flange 67 of the needle hub 27 approaches the flange 101, the flange 67 will also engage the locking fingers 103. The backward movement of the flange 67 causes an outward deflection of the locking fingers 103. However, when the flange 67 abuts the proximal flange 101, the locking fingers 103 resiliently return to a non-deflected condition and engage the distal face of the flange 67. Therefore, a return movement of the needle part 7 is prevented. Furthermore, the internally aligned orientation of the locking fingers 103 substantially prevents any intentional outward deflection of the locking fingers 103 that would allow a re-exposure of the needle cannula 25. Therefore, reuse of the needle cannula 25 can be achieved only by substantially complete destruction of the locking fingers 103 on the rear drum 13.

[074] With respect to FIG. 16, an alternative embodiment of the blood collection/infusion assembly 201 includes a length of flexible tubing 203, a needle assembly including a needle cannula 205, a spring (not shown), a barrel assembly comprising a barrel. front 207, a rear drum 209 and a finned frame 211, and a skin sensor pivot lever 213.

[075] The needle cannula 205 has a proximal end supported by a needle hub positioned within the front barrel 207, a distal end 215 and a lumen extending between the ends. The distal end 215 of the needle cannula 205 is bevelled to a sharp puncture tip 217, such as an intravenous puncture tip. The puncture tip 217 is provided for insertion into a patient's blood vessel, such as a vein, and is then designed to provide easy insertion and minimal discomfort during venipuncture.

[076] The skin sensor pivot lever 213 includes a front door 219 and a rear 221. The skin sensor pivot lever 213 is coupled to the front drum 207 with a pivot shaft 223 substantially perpendicular to an axis of the front drum 207 and the needle cannula 205. The pivot shaft 223 is generally located on a lower surface of the front barrel 207. The front 219 interfaces with the patient injection point by passing through the needle cannula 205 and the rear 221 does. interface with the needle hub (not shown). The front part 219 of the Skin Sensor Pivot Lever 213 moves up and down, with the upward direction being away from the patient's injection point and the downward direction being towards the injection point. The front 219 of the skin sensor pivot lever 213 is configured to interface with a patient injection point through the needle cannula 205, and may be further configured to include a hollow pad. The hollow cushion offers more surface area and patient comfort. The front 219 of the skin sensor pivot lever 213 is further configured to be lower than the needle cannula 205 when in an initial downward position. The rear part 221 also moves up and down, opposite the front part 219 due to the location of the pivot shaft 223. The pivot shaft 223 can be formed by a pin and hole arrangement, where the pivoting lever with sensor of skin 213 is a separate component of front drum 207. Pivot shaft 223 may alternatively be molded integrally with front drum 207. In that case, pivot shaft 223 may comprise two thin flexible elements that create a hinge that is integral with front drum 207.

[077] The use of this modality is as follows. First, the healthcare professional guides puncture tip 217 of needle cannula 205 into a target location on the patient and employs a proximal hub (not shown) on a proximal end of tube 203 for connection to an evacuated container or source of fluid that will be infused into the patient. As the needle cannula 205 is inserted into the patient, the front 219 of the skin sensor pivot lever 213 is forced to move upward to at least the level of the needle cannula 205. of the skin sensor pivot lever 213 goes through the needle cannula 205 and does not hide the same or the injection site. Furthermore, this hollow arrangement also acts as a guide to help locate the ideal puncture site. Upward movement of the front part 219 of the skin sensor pivot lever 213 causes an engagement element (not shown) to disengage a first recess in a needle hub (not shown) and allows a needle hub to slide a distance minimum backward until stopped by engagement of another engagement element (not shown) with a second recess in the needle hub. The 213 Skin Sensor Pivot Lever remains in this configuration during injection or infusion. Upon completion of the medical procedure, the healthcare professional removes the 205 needle cannula from the patient. Removal of the needle cannula 205 causes the front part 219 of the skin sensor pivot lever 213 to move down to its original position. This results in the other engagement element being moved up and out of the second recess. Therefore, a drive element (not shown) is allowed to expand and propel the needle hub proximally. Proximal movement of the needle hub ends when the entire needle cannula 205 is securely disposed within the front and rear barrels 207 and 209.

[078] FIGs. 17 to 19 describe a further embodiment of the invention, incorporating an alternating retention and release mechanism between the lever and the hub. The embodiment described in FIGs. 17-19 includes components similar to those shown in FIGs. 12 to 15, and such like components are identified with like reference numerals and further include the designation "a". For example, the blood collection/infusion set of FIGs. 17-19 includes a length of flexible tubing 3a, a needle assembly including a needle cannula 25a, a spring 9a, a barrel assembly comprising a front barrel 11a, a rear barrel 13a, and a skin sensor pivot lever 16a .

[079] The needle cannula 25a has a proximal end supported by a needle hub 27a positioned within the barrel assembly, a distal end defining an IV puncture tip 35a, and a lumen extending between the ends. The puncture tip 35a is provided for insertion into a patient's blood vessel, such as a vein, and is then designed to provide easy insertion and minimal discomfort during venipuncture.

[080] The skin sensor pivot lever 16a includes a front part 49a and a rear part 51a. The front part 49a interfaces with the patient injection point by passing through the needle cannula 25a, while the back part 51a interfaces with the needle hub 27a, as will be described in more detail here. The skin sensor pivot lever 16a is coupled to the front drum 11a forming a pivot shaft 53a. The front drum 11a further includes an opening 91a extending through the top wall surface thereof, sized and configured to receive the rear portion 51a of the skin sensor pivot lever 16a and permit engagement of the rear portion 51a with the needle cube 27a.

[081] As with the embodiment described in conjunction with FIGs. 12-15, the pivot shaft 53a may be formed through a lever bar arrangement, where the rear portion 51a of the skin sensor pivot lever 16a includes pin 52a connected to front drum 11a. For example, parts of the wall forming the front drum 11a may be cut on opposite sides thereof to accommodate the pin 52a in a socket, providing a hinge-type pivotal engagement about the pivot shaft 53a in a manner similar to that described above in together with FIGs. 12 to 15.

[082] The rear part 51a of a lever 16a interfaces with the needle hub 27a to hold it against spring 9a activation. In particular, the needle hub 27a may include a recess 312 that extends across a portion of the top surface. Recess 312 is configured to accommodate pin 52a positioned at the rear 51a of lever 16a in a rotational fashion, and then includes an inner surface that matches the generally cylindrical outer surface profile of pin 52a. The pin 52a is provided with a recessed portion which extends between the side ends of the pin 52a at a center cutting portion 310. The center cutting portion 310 may be in the form of a pie-shaped wedge cut from the center portion of the section. The generally cylindrical cross-section of the pin 52a, defining the wedge faces 320, 322. Desirably, the wedge faces 320 and 322 intersect at an angle greater than 90° at the pivot axis 53a of the pin 52a, forming the center cutting portion. 310 as an obtuse angle. The outer surface 314 of the pin 52a together with the wedge faces 320, 322 in the central cutting portion 310 is designed to interact with the inner surface of the recess 312 so as to retain the needle hub 27a in a forward position against the force of the spring 9a.

[083] In particular, as shown in FIG. 17, an interference engagement is established between the outer surface 314 of the pin 52a and the recess 312 of the needle hub 27a, with the outer surface 314 acting as a first engagement portion, thereby holding the needle hub 27a in place. against activation of spring 9a. As the needle cannula 25a is inserted into the patient, the front portion 49a of the skin sensor pivot lever 16a is forced to move upwards to at least the level of the needle cannula 25a. Upward movement of the front part 49a of the skin sensor pivot lever 16a causes the pin 52a to rotate about the pivot axis 53a, as shown in FIG. 18. Such rotation causes wedge face 320 to rotate out of interference engagement with bearing 316 on the top surface of needle hub 27a. As such, pin 52a is essentially disengaged from a first position retaining needle hub 27a, and may further allow needle hub 27a to slide a minimum distance back, with wedge surface 322 contacting an edge portion at the edge. front of the recess 312, thus acting as a second engagement part to hold the engagement hub 27a against activation of the spring 9a. The Skin Sensor Pivot Lever 16a remains in this configuration during injection or infusion. Upon completion of the medical procedure, the healthcare professional removes the 25a needle cannula from the patient. Removal of the needle cannula 25a causes the front part 49a of the skin sensing pivot lever 16a to move down to its original position, causing the pin 52a to rotate about the pivot axis 53a in a reverse direction. Such a back turn causes wedge face 320 to run around bearing 316 and along bearing face 318, which extends to a reduced profile channel surface that extends along the top surface of the hub. needle 27a towards flange 67a. Such back or reverse pivotal movement causes wedge face 322 to rotate out of interference engagement with the edge portion on the leading edge of recess 312. In this way, needle hub 27a is released from interference engagement, allowing as spring 9a expands and pushes needle hub 27a proximally or backwards. Such proximal movement of the needle hub ends when the proximal or rear end 59a of the needle hub 27a contacts the proximal flange 101a, with the entire needle cannula 25a securely disposed within the front and rear barrels 11a and 13a , as depicted in FIG. 19.

[084] The protection feature of the present invention is passively activated upon normal use of the device. In particular, upon contact with a patient's skin and/or during venipuncture, the safety feature is initiated and loaded, ready to protect the needle upon its removal from the patient's skin. Consequently, the user is not required to use any active steps to effect the needle safety guard, thus automatically providing an effective safety feature through normal operation.

[085] While the modalities of the present invention have been described with respect to the various figures of the passive retraction needle with skin sensor, those skilled in the art can modify and alter them. Consequently, the description detailed above is intended to be illustrative rather than restrictive. The embodiments of the invention are defined by the appended claims, and all changes which are within the understanding and equivalence range of the claims will be encompassed within its scope.

Claims (20)

1. A safety needle device, comprising: a hub (27) including a passageway extending therethrough and a needle cannula (25) with a puncture tip (35) extending from its forward end; a protective element (8) in telescopic association with the hub (27), at least one of the hub (27) and the protective element (8) adapted for relative telescopic movement with respect to the other between a first position, in which the puncture tip (35) of the needle cannula (25) is exposed from a forward end of the protective element (8), and a second position, in which the puncture tip (35) of the needle cannula (25 ) is enclosed within the protective element (8); and a drive element (9) disposed between the hub (27) and the protection element (8) and capable of activating the hub (27) and the protection element (8) telescopically away from each other; CHARACTERIZED by the fact that a contact element comprises a lever (16) in pivotal engagement with the protective element (8) including a forward portion (49) adjacent to the punch tip (35) of the needle cannula (25) and a rear portion (51) including a frame for releasably holding the hub (27) and guard element (8) in the first position, the rear part (51) of the lever (16) being pivotally connected to the guard element (8), the contact element adapted to hold the hub (27) and the protective element (8) in the first position against activation of the actuating element (9) with the needle cannula (25) exposed from the end front of the protective element (8), and the movable contact element during contact with a surface, thus allowing the release of the hub (27) and the protective element (8) from the first position and allowing the actuation element ( 9) activate at least one of the hub (27) and the protection element (8) and m toward the second position. 2. Safety needle device, according to claim 1, CHARACTERIZED by the fact that the release of the surface contact element allows the actuating element (9) to activate at least one of the hub (27) and the element guard (8) telescopically away from each other to the second position with the puncture tip (35) of the needle cannula (25) enclosed within the guard element (8). 3. Safety needle device according to claim 1, CHARACTERIZED by the fact that the rear part (51) of the lever (16) includes a first engaging element (55) for engaging with the hub (27) to hold the hub (27) and the protective element (8) in the first position, the first engagement element (55) being releasable from engagement with the hub (27) upon pivotal movement of the lever (16) during contact with a surface . 4. Safety needle device, according to claim 3, CHARACTERIZED by the fact that the rear part (51) of the lever (16) additionally includes a second engaging part for engaging with the hub (27) through pivotal movement of the lever (16) during contact with a surface to prevent the hub (27) from being activated fully into the second position when the first engagement part is released from engagement with the hub (27). 5. Safety needle device according to claim 4, CHARACTERIZED by the fact that the second engagement part is released from engagement with the hub (27) by pivoting movement of the lever (16) in a reverse direction during release of contact with a surface. 6. Safety needle device according to claim 5, CHARACTERIZED by the fact that the first engagement part comprises a first engagement element (55) and the second engagement part comprises a second engagement element (57). 7. Safety needle device, according to claim 5, CHARACTERIZED by the fact that the lever (16) includes a pivot pin (52) to effect pivotal movement of the lever (16) around a pivot axis (53) , and where the first engagement portion comprises a first outer pivot pin portion (52), and where the second engagement portion comprises a second outer pivot pin portion (52). 8. Safety needle device according to claim 7, CHARACTERIZED by the fact that the pivot pin (52) is substantially cylindrical including a wedge-shaped cutting part, where the first outer part of the pivot pin (52) comprises an outer cylindrical surface of the pivot pin (52) and where the second outer part comprises a wedge-shaped face of the cutting part. 9. Needle guard assembly (2), CHARACTERIZED in that it comprises: a needle cannula (25) with a puncture tip (35) at a distal end thereof; a needle hub (27) supporting the needle cannula; a barrel (11, 13) having a proximal end, a distal end and a passage extending between the ends, the needle hub (27) being disposed in the passage of the barrel (11, 13); a drive element (9) disposed between the barrel (11, 13) and the needle hub (27) for driving the needle hub (27) from a first position, in which the punch tip (35) of the cannula needle (25) is exposed from the distal end of the barrel (11, 13) to a second position where the puncture tip (35) of the needle cannula (25) is disposed entirely within the barrel (11, 13); and a lever (16) pivotally connected to the barrel (11, 13) and including a forward portion (49) adjacent the needle cannula (25) when the needle hub (27) is in the first position and adapted to contact a surface of the patient's skin and a rear portion (51) including a releasable engagement with the needle hub (27) to hold the needle hub (27) in the first position, the rear portion (51) of the lever (16) being connected pivotally to the drum (11, 13), where the contact of the front (49) of the lever (16) with the patient's skin surface rotates the lever (16) and releases an initial engagement with the needle hub (27 ) on the rear (51) of the lever (16). 10. Needle assembly with protection (2), according to claim 9, CHARACTERIZED by the fact that the rear part (51) of the lever (16) includes a first engaging part that engages a part of the needle hub ( 27), thus keeping the needle hub (27) in the first position. 11. Needle set with protection (2), according to claim 9, CHARACTERIZED by the fact that the contact of the front (49) of the lever (16) with the patient's skin surface, the insertion of the needle cannula (25) through the patient's skin surface, or contacting the front (49) of the lever (16) with the patient's skin surface and inserting the needle cannula (25) through the patient's skin surface makes with the lever (16) to rotate with respect to the drum (11, 13) so that the first lever engaging part (16) disengagement from the needle hub (27) and the second lever engaging part (16) maintain the needle hub (27) in a position with the punch tip (35) extending from the forward end of the barrel (11, 13). 12. Needle assembly with protection (2), according to claim 9, CHARACTERIZED by the fact that the rear part (51) of the lever (16) additionally includes a second engagement part for engagement with the needle hub (27 ), and where the contact of the front (49) of the lever (16) with the surface of the patient's skin, the insertion of the needle cannula (25) through the surface of the patient's skin, or the contact of the front (49) ) of the lever (16) with the patient's skin surface and insertion of the needle cannula (25) through the patient's skin surface causes the lever (16) to rotate with respect to the drum (11, 13) so that the first lever engaging portion (16) disengages the needle hub (27) and the second lever engaging portion (16) hold the needle hub (27) in a position with the punch tip (35) if extending from the front end of the drum (11, 13). 13. Needle set with protection (2), according to claim 12, CHARACTERIZED by the fact that the second lever engagement part (16) disengages the needle hub (27) by pivoting movement of the lever (16) with relative to the barrel (11, 13) in a reverse direction when removing the front (49) of the lever (16) from the patient's skin surface or when removing the needle cannula (25) from the patient's skin surface, thereby causing the drive element (9) to drive the needle hub (27) to a position where the punch tip (35) of the needle cannula (25) is disposed entirely within the barrel (11, 13). 14. Needle set with protection (2), according to claim 9, CHARACTERIZED by the fact that the drive element (9) comprises a spiral spring. 15. Needle set with protection (2), according to claim 9, CHARACTERIZED by the fact that the lever (16) is molded integrally to the drum (11, 13). 16. Needle set with protection (2), according to claim 9, CHARACTERIZED by the fact that the lever (16) is pivotally connected to the drum (11, 13) through a pivot pin (52). 17. Needle set with protection (2), according to claim 9, CHARACTERIZED by the fact that the front part of the pivoting lever (16) is configured to interface with a patient injection point crossing the puncture tip ( 35) of the needle cannula (25). 18. Needle set with protection (2), according to claim 17, CHARACTERIZED by the fact that the front part of the pivot lever (16) comprises a hollow pad. 19. Blood collection set, CHARACTERIZED by the fact that it comprises the needle set with protection (2), as defined in claim 9, including a flexible tube that extends from the needle hub (27), the flexible tube comprises a needle cannula (25) opposite the patient at an opposite end and adapted for connection to a receptacle to accommodate a blood collection tube. 20. Method for activating a needle assembly, CHARACTERIZED in that it comprises: providing a needle assembly comprising a hub (27) including a needle cannula (25) with a puncture tip (35) extending from at a forward end thereof, the hub (27) is at least partially disposed within a protective element (8) and activated towards a position in which the puncture tip (35) of the needle cannula (25) is enclosed within the protective element (8), the needle assembly further comprises a pivoting lever (16) connected to the barrel (11, 13) and including a first engagement with the hub (27) to keep said hub (27) activated against the tip. punch (35) exposed from a front end of the shield; insert the puncture tip (35) of the needle cannula (25) through a patient's skin such that the pivot lever (16) contacts the patient's skin surface which is to be pierced and does with that the lever (16) rotates with respect to the protective element (8), thus removing the first engagement between the lever (16) and the hub (27) and removing the punch tip (35) from the needle cannula (25) of the patient's skin so that the pivoting lever (16) releases from contact with the patient's skin surface and rotates with respect to the guard member (8) in an opposite direction, thus releasing the second engagement between the lever (16 ) and the hub (27), and allowing the hub (27) to be activated towards a position in which the puncture tip (35) of the needle cannula (25) is enclosed within the protective element (8).

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